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Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Wake Forest Baptist Health Identifier:
First received: March 8, 2002
Last updated: August 20, 2009
Last verified: August 2009

RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in limiting weight loss in patients who are undergoing radiation therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss in patients who are undergoing radiation therapy for lung cancer.

Condition Intervention Phase
Lung Cancer
Drug: megestrol acetate
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: A Phase III, Double-Blind, Randomized Study of the Effect of Megestrol Acetate on Weight and Health Related Quality of Life in Lung Cancer Patients Receiving Thoracic Radiation Therapy

Resource links provided by NLM:

Further study details as provided by Wake Forest Baptist Health:

Study Start Date: September 2000
Detailed Description:


  • Determine the effect of megestrol on weight in patients receiving radiotherapy for lung cancer.
  • Determine the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to histology (non-small cell lung cancer vs small cell lung cancer), and type of treatment (radiotherapy vs radiotherapy and non-cisplatin-containing chemotherapy vs radiotherapy and cisplatin-containing chemotherapy). Patients are randomized to one of two treatment arms.

All patients undergo thoracic radiotherapy beginning on week 1 and continuing for a total of 5-7 weeks.

  • Arm I: Patients receive oral megestrol once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy.
  • Arm II: Patients receive oral placebo once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy.

In both arms, quality of life is assessed at baseline, at the completion of radiotherapy, and at 4, 8, 12, 16, and 20 weeks after the completion of radiotherapy.

Patients are followed at 4 and 8 weeks.

PROJECTED ACCRUAL: A total of 98 patients (49 per treatment arm) will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed lung cancer

    • Unresectable stage I-IIIB non-small cell lung cancer (NSCLC)
    • Resected stage I-IIIB NSCLC
    • Limited stage small cell lung cancer
  • Planned radiotherapy with a total dose of at least 5,000 cGy in fraction sizes of no greater than 200 cGy each
  • No distant metastases
  • No significant ascites, pleural effusions, or edema that would inhibit oral food intake or invalidate weight determinations



  • Over 18

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months


  • Not specified


  • Not specified


  • Not specified


  • No uncontrolled hypertension
  • No active thromboembolic disease
  • No myocardial infarction within the past 3 months
  • No prior congestive heart failure or thromboembolic events


  • No prior pulmonary edema


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer
  • No uncontrolled diabetes with glycosylated hemoglobin greater than 10%
  • No Cushing's syndrome
  • No dietary restrictions (e.g., salt, sugar, or lipid)
  • No other serious medical or psychiatric illness that would preclude study


Biologic therapy:

  • Not specified


  • See Endocrine therapy

Endocrine therapy:

  • At least 12 months since prior corticosteroids, estrogens, progestins, or other steroid hormone except as antiemetic prior to chemotherapy
  • No concurrent corticosteroids, estrogens, progestins, or other steroid hormone except as antiemetic prior to chemotherapy


  • See Disease Characteristics
  • No prior radiotherapy to lung


  • See Disease Characteristics
  • More than 14 days since prior surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00031785

United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Wake Forest Baptist Health
National Cancer Institute (NCI)
Study Chair: Edward G. Shaw, MD Comprehensive Cancer Center of Wake Forest University
  More Information Identifier: NCT00031785     History of Changes
Other Study ID Numbers: CDR0000069226  CCCWFU-98199  NCI-P02-0210 
Study First Received: March 8, 2002
Last Updated: August 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Baptist Health:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
limited stage small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants processed this record on December 02, 2016